NCT07251504Completed
Mitochondrial Metabolism and Oxidative Stress in Function of the Physical Exercise and Nutritional Counseling in T2DM
Mitochondrial Metabolism and Oxidative Stress in Function of the Type of Physical Exercise and Nutritional Counseling in Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
The goal of this ancillary study is to learn about the effects of different aerobic modalities (moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT)) and diet on mitochondrial properties and oxidative stress in patients with prediabetes or type 2 diabetes (T2D), and overweight or obesity. It will also learn about the different effects of these interventions in men and women. The main questions it aims to answer are: * What is the isolated and combined effect of these exercise modalities and diet? Is there a superior approach for mitochondrial metabolism and oxidative stress in patients with T2D? * Is there a sex-specific best combination choice for these different interventions? * Is there any relation between exercise and diet-induced changes in mitochondrial properties and oxidative stress and other health-related outcomes such as body composition or insulin sensitivity? To answer these questions, researchers designed a two-factor study. One factor was exercise, which had three levels (MICT, HIIT, and the inactive (INACT) condition). The second factor was diet, with two levels (Diet (D) and no diet (ND)). Hence, participants were randomly allocated into 6 groups: INACT-ND, INACT-D, MICT-ND, MICT-D, HIIT-ND, and HIIT-D. Participants did: * Underwent a 12-week intervention within the condition of his/her group * Visit the research group facilities three times per week if in an exercise group or once every two weeks if in a diet group.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 146 (actual)
- First submitted
- 26 Sept 2025
- Start date
- 10 Mar 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Cadiz
- Diseases
- Type 2 diabetes
- NCT number
- NCT07251504
What you commit to
- Study type: Interventional
- Participants enrolled: 146
- From 10 Mar 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Failure to attend more than 2 consecutive sessions or a total of 4 sessions of nutritional intervention.
- Failure to attend more than 4 consecutive or a total of 6 sessions of physical training.
- Increased dose of diabetes medication
Other
- Serious injury
- Voluntary withdrawal
Who the study is looking for
- Diagnosis of T2D or prediabetes (glycated hemoglobin ≥ 5.7%)
- No history of substance abuse (tobacco, alcohol, or other drugs).
- Body mass index ≥25 kg/m², maintaining habitual dietary patterns with stable body weight for at least 6 months
- Stable physical activity and medication regimen for at least 6 months
- Lack of habitual vigorous-intensity physical activity and the presence of sedentary behavior characterized by prolonged sitting time (screened using the International Physical Activity Questionnaire short form).
- Not insulin-dependent
- Absence of injury, disease, disability, or other known medical condition which could affect the ability to successfully participate in physical exercise tests
- Absence of tumors and cancer disease
- Absence of other pathologies that could affect the study outcomes.
- Not on a medication regimen that could affect the study outcomes.
- Being able to understand communication in Spanish or English.
- Not pregnant
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Science of Education Faculty Coordinator of this site? Confirm its status | Puerto Real | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.